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WHAT IS VIVITROL® (naltrexone for extended-release injectable suspension)?

VIVITROL is a prescription injectable medicine used to:

Treat alcohol dependence. You should stop drinking before starting VIVITROL.

Prevent relapse to opioid dependence after opioid detox. You must stop taking opioids or other opioid-containing medications before starting VIVITROL.

VIVITROL must be used with other alcohol or drug recovery programs such as counseling.

VIVITROL may not work for everyone and has not been studied in children.

DO NOT TAKE VIVITROL IF YOU:

Are still using or still have any symptoms of physical withdrawal due to dependence on opioid street drugs or opioid-containing medicines.

Have opioid withdrawal symptoms.

Are allergic to naltrexone or any of the ingredients in VIVITROL or the liquid used to mix VIVITROL.

See the Medication Guide for more information about opioid withdrawal and the ingredients in VIVITROL and the liquid used to mix it.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT VIVITROL?

VIVITROL CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

RISK OF OPIOID OVERDOSE

Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death. To avoid accidental overdose:

Do not take large amounts of opioids or try to overcome the opioid-blocking effects of VIVITROL.

Do not use opioids in amounts that you used before VIVITROL treatment. You may even be more sensitive to lower amounts of opioids:

After detox

When your next VIVITROL dose is due.

If you miss a dose of VIVITROL.

After you stop VIVITROL treatment.

Get emergency medical help right away if you have trouble breathing; become very drowsy with slowed breathing; have slow, shallow breathing; feel faint, dizzy, confused; or have other unusual symptoms.

SEVERE REACTIONS AT THE INJECTION SITE

VIVITROL may cause severe injection site reactions, including tissue death. Some injection site reactions have required surgery. Call your doctor right away if you notice any of the following at your injection site:

Intense pain

The area feels hard

Swelling

Lumps

Blisters

An open wound

A dark scab

Tell your doctor about any injection site reaction that concerns you, gets worse over time or does not get better by two weeks after the injection.

SUDDEN OPIOID WITHDRAWAL

To avoid sudden opioid withdrawal, you must stop taking any opioids or opioid-containing medications, including buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. If your doctor decides that you don’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat sudden opioid withdrawal.

Sudden opioid withdrawal can be severe and may require hospitalization.

LIVER DAMAGE OR HEPATITIS

Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis. Tell your doctor if you have any of the following symptoms of liver problems during VIVITROL treatment:

Stomach area pain lasting more than a few days

Yellowing of the whites of your eyes

Dark urine

Tiredness

OTHER POSSIBLE SIDE EFFECTS

VIVITROL can cause other serious side effects, such as:

Depressed mood – Sometimes this leads to suicide or suicidal thoughts and behavior. Tell those closest to you that you are taking VIVITROL. You or those closest to you should call your doctor right away if you become depressed or have any new or worsening depression symptoms.

Allergic pneumonia – Tell your healthcare provider if you have shortness of breath, wheezing, or a cough that doesn’t go away.

Serious allergic reactions – Get medical help immediately if you have a skin rash; swelling of your face, eyes, mouth, or tongue; trouble breathing or wheezing; chest pain; or are feeling dizzy or faint.

Common side effects of VIVITROL include nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps; in addition, common side effects in people taking VIVITROL for opioid dependence also include cold symptoms, trouble sleeping, and toothache.

These are not all of the side effects of VIVITROL. For more information, ask your healthcare provider. Tell your doctor right away if you have any side effect that does not go away. See the Medication Guide for more information.

Call your doctor for medical advice about any side effects. You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Terms and Conditions

The Provider Locator is compiled and published by Alkermes, Inc. as a reference source of demographic and professional information on individual licensed healthcare providers in the United States who have experience in the treatment of alcohol dependence and/or opioid dependence. The Provider Locator is searchable by zip code or by city and state. Healthcare providers' enrollment and participation in the Provider Locator is voluntary and free of charge and, along with the provider-specific information in the Provider Locator, is based solely on healthcare provider responses. The Provider Locator is provided by Alkermes for use by the medical and addiction treatment communities, potential patients and/or their families in order to find information on, and locate healthcare providers for the treatment of alcohol dependence or opioid dependence. Alkermes is not responsible for, and the Provider Locator is not intended as a tool for, verifying the credentials, expertise, abilities or quality of care of any healthcare provider included in the Provider Locator. Inclusion in the Provider Locator does not imply referral, recommendation or endorsement nor does omission in the Provider Locator imply Alkermes' disapproval. We recommend that, before scheduling an appointment to see any healthcare provider, you research the credentials of the healthcare provider and satisfy yourself that the healthcare provider provides the quality of care desired. You are prohibited from using, downloading, republishing, selling, duplicating, or "scraping" for commercial or any other purpose whatsoever, the Provider Locator or any of the data listings or other information contained therein, in whole or in part, in any medium whatsoever. The information from the Provider Locator is provided on an "AS-IS" basis. Alkermes disclaims all warranties, either express or implied, including but not limited to the implied warranties of merchantability and fitness for particular purpose. Without limiting the foregoing, Alkermes does not warrant or represent that the Provider Locator or any part thereof is accurate or complete. You assume full responsibility for the communications with any healthcare provider you contact through the Provider Locator. Alkermes shall in no event be liable to you or to anyone for any decision made or action taken by you in the reliance on information.